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May 2009

Good and Bad Responses to 483s

Preparing a response to a Form FDA 483 can be a time-consuming and stressful process. It diverts resources from other activities and, if not managed properly, the process can be overwhelming. If a 483 response is well written, factually correct and complete, it will establish that the firm has taken or is in the process of taking appropriate corrective and preventive action. This can allay FDA concerns about the firm's compliance, and reflect positively on the organization. If the response is poorly written, contains errors or omits critical information, it can trigger additional inspections or a Warning Letter. If the firm submits inadequate responses to a Warning Letter, the firm is at risk for seizures, suspension of product approvals, injunctive action or possibly criminal prosecution. While this article is focused on 483 responses, the recommendations apply equally to Warning Letters.

Some firms use template responses, directing staff to use boilerplate language to respond to certain types of observations. This is a mistake. Firms that adopt a "check the box" or "fill in the blank" approach to 483 responses do so at their own peril. Crafting an acceptable response requires thoughtful analysis and precision. Following the three rules below will make this exercise more efficient and productive.

The response is an opportunity to communicate to the agency that you understand your compliance obligations. It is also an opportunity to demonstrate that you have corrected, or will correct, any deficiencies identified in the response and ensure that the problems do not recur. Most importantly, the response needs to demonstrate that your firm is operating in a state of control.

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